| ISO 8536-11 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 6-361 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 9.3 Label on shelf or multi-unit container. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536 8. It does not include the effectiveness of filters for separation of particles or germs.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5440 | Set, Administration, Intravascular | Class 2 | FPA |
| Intravascular Administration Sets Premarket Notification Submissions [510(k)] - Guidance for Industry and FDA , Issued July 2008. |